A Pilot Study to Evaluate the Efficacy and Safety of Neoadjuvant Chemoradiotherapy With Capecitabine, . . . (PMABIIS)

This study has been withdrawn prior to enrollment.
(Study never went beyond FDA application for an IND #. FDAA required institutional DSMC which this institution then lacked.)
Sponsor:
Information provided by:
University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01130701
First received: May 24, 2010
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

In this study, a new chemotherapeutic agent, panitumumab, will be tested in combination with another chemotherapeutic drug, capecitabine, along with external radiotherapy, to find out whether this combination is effective and safe to use before surgery.


Condition Intervention Phase
Pancreatic Cancer
Other: Neoadjuvant capecitabine, panitumumab and radiation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Pilot Study to Evaluate the Efficacy and Safety of Neoadjuvant Chemoradiotherapy With Capecitabine, Panitumumab and External Beam Radiation, in Patients With Localized, Non-Metastatic Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • To estimate the 3 year progression-free survival of patients with localized, resectable pancreatic cancer [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
    To estimate the proportions of patients (with localized, resectable and borderline resectable, non-metastatic pancreatic adenocarcinoma) treated with the study regimen alive at 2-years from the date of registration.


Secondary Outcome Measures:
  • To estimate resection rate [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
    To determine the fraction of patients that proceed to planned surgery with the removal of primary tumor (R0/R1) following neoadjuvant therapy; estimate the overall survival in this patient population; evaluate the rate of R0, R1 and R2 resection (defined as per 6th edition of AJCC Cancer Staging Manual) in patients treated with neoadjuvant therapy; the overall response rate to chemoradiation therapy; the biomarker response to chemoradiation through evaluation of circulating CA19-9 levels; to evaluate the toxicity associated with this regimen.


Estimated Enrollment: 78
Study Start Date: May 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Neoadjuvant capecitabine, panitumumab and radiation

    Patients will receive six weekly doses of panitumumab (2.5mg/kg) in conjunction oral capecitabine 825 mg/m2 PO bid Mon-Friday and external beam radiation therapy. Panitumumab and oral capecitabine will begin on the first week of external beam radiotherapy and will continue throughout the course of external beam radiation therapy, and will be discontinued following the conclusion of external beam radiation therapy.

    Patients will be reevaluated for surgical resection 4-6 weeks after completion of neoadjuvant therapy.

    After surgical resection, adjuvant systemic chemotherapy with gemcitabine for six months is strongly recommended for all patients.

    Other Names:
    • Xeloda
    • Vectibix; NSC # 742319
Detailed Description:

Surgical resection remains the standard procedure for patients with localized resectable pancreatic cancer.

Neoadjuvant or preoperative therapy with chemotherapy and radiation therapy has been proposed as an alternative approach in patients with localized pancreatic adenocarcinoma.

Advantages are: 1) early start of systemic therapy targeting micrometastatic disease; 2) increased compliance with chemoradiotherapy; 3) increase primary tumor complete resection rates; 4) avoidance of surgery in patients with rapidly developing metastatic disease; and 5) importantly, it provides an important resource for research in terms of tissue acquisition before and after therapy . Finally, this is an opportunity to test the safety and efficacy of a novel combination of weekly panitumumab, oral capecitabine and radiation in pancreatic cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Cytological or histological confirmation of pancreatic adenocarcinoma is required.
  2. Only patients with localized and apparently resectable, non-metastatic tumors are eligible. All patients must be staged with a chest X-ray or chest CT and abdominal and pelvic CT scan or MRI.

    One of the following radiological criteria must be met and recorded in chart by dedicated surgeon prior to enrollment.

    A)Localized, potentially resectable : 1) no evidence of tumor extension to the celiac axis, hepatic artery or superior mesenteric artery; 2) no evidence of tumor encasement or occlusion of superior mesenteric vein (SMV) or the SMV/portal vein(PV) confluence; 3) no evidence of visceral or peritoneal metastasis

    B)Borderline resectable: 1) no extra pancreatic disease, (2) the following possible tumor-vessel relationships: an SMV-PV confluence that can be reconstructed even if short segment venous occlusion is present; tumor abutment of the SMA of ≤180°; or short segment encasement of the hepatic artery amenable to resection and reconstruction.

    Patients with the following radiological criteria are NOT eligible:

    A) Locally advanced disease: (1) no extra pancreatic disease, (2) tumor encasement of the SMA or celiac axis defined as tumor involvement of >180° of the arterial circumference. B) Radiographic evidence of distant organ or peritoneal metastases.

  3. Age > 18 years.
  4. ECOG performance status 0 and 1.
  5. Patient must have adequate hematological, renal and hepatic function defined as:

    WBC > 2,000 cells/mm3 ANC>1500 cells/mm3 Hemoglobin > 9.0 g/dL Platelets > 100,000 cells/mm3 Serum creatinine < 1.5 x upper limit of normal (UNL) or a calculated creatinine clearance of > 50 mL/min calculated by Cockcroft-Gault method Total bilirubin < 2.5 mg/dl AST < 3x upper limits of normal ALT < 3x upper limits of normal

  6. Serum calcium and magnesium levels within limits of normal
  7. Patients may not have any prior therapy for carcinoma of the pancreas, nor prior abdominal radiation therapy.

Exclusion Criteria:

  1. Patients with any other malignancy within 5 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
  2. Psychiatric illness which would prevent the patient from giving informed consent.
  3. Serious medical illness which would limit anticipated survival to < 12 weeks.
  4. Protocol treatment would pose significant risk to an unborn child. Pregnant women should not be enrolled, and women of child-bearing age should be strongly encouraged to practice effective birth control during and for six months after the trial. Non-pregnant and non-breast-feeding. Female participants of child-bearing potential must have a negative urine or serum pregnancy test prior to registration. Perimenopausal participants must be amenorrheic > 12 months to be considered not of childbearing potential. All patients (men and women) of reproductive potential must agree to use an effective method of birth-control while receiving study therapy and for six months after completion of therapy.
  5. Inability to swallow medication. Patients should have adequate, unassisted oral intake.
  6. Inability to hold still and cooperate during radiotherapy.
  7. Prior history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130701

Locations
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Bilal Piperdi, MD University of Massachusetts, Worcester
  More Information

Publications:
Responsible Party: Bilal Piperdi, MD, University of Massachusetts Medical School
ClinicalTrials.gov Identifier: NCT01130701     History of Changes
Other Study ID Numbers: UM2010-01
Study First Received: May 24, 2010
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
Pancreatic Cancer
Neoadjuvant
Panitumumab
Capecitabine

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014